VOTRIENT FILM-COATED TABLET 400MG

מדינה: מלזיה

שפה: אנגלית

מקור: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

מרכיב פעיל:

PAZOPANIB HYDROCHLORIDE

זמין מ:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (שם בינלאומי):

PAZOPANIB HYDROCHLORIDE

יחידות באריזה:

30 Tablets; 60 Tablets

תוצרת:

Siegfried Barbera, S.L.

עלון מידע

VOTRIENT
®
Pazopanib Hydrochloride (200mg, 400mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What VOTRIENT is used for
2.
How VOTRIENT works
3.
Before you use VOTRIENT
4.
How to use VOTRIENT
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of VOTRIENT
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT VOTRIENT IS USED FOR
VOTRIENT is used as a single agent to
treat advanced or metastatic (has spread
to other organs) renal cell carcinoma
(RCC), which is a form of kidney cancer
that involves cancerous changes in the
cells of the renal tubule. It prevents the
activity of a special group of proteins
which are known to be involved in the
growth and spread of cancer cells.
VOTRIENT is used as a single agent to
treat certain forms of advanced soft
tissue sarcoma (STS), which is a type of
cancer that affects the supportive tissues
of the body. It can occur in muscles,
blood vessels, fat tissue or other tissues
that support, surround and protect the
organs.
HOW VOTRIENT WORKS
Votrient works by preventing the activity
of proteins that are involved in the
growth and spread of cancer cells.
BEFORE YOU USE VOTRIENT
_Before you start to use it _
If any of these apply to you, tell your
doctor before taking VOTRIENT:
•
If you have heart disease
•
If you have had heart failure or a
heart attack
•
If you have problems with your
blood pressure
•
If you have liver disease
•
If you have problems with bleeding
•
If you have had prior blood clots in a
vein or in a lung
•
if you have gastrointestinal problems
•
if you have thyroid problems
•
If you had prior collapse of a lung
•
if you are going to have a surgical or
dental procedure, or if you have had
either recently.
•
If you have problems with your
kidney function
•
If you have or have had an aneurysm
(enlargement and weakening of a
blood vessel wall) or a tear in a
blood vessel wall
Check with your doctor if you think any
of these may apply to you. You may
nee

מאפייני מוצר

Novartis
03 Jun 2021
Page 2
Malaysia Package Leaflet
Votrient
®
VOTRIENT
®
Antineoplastic agents – Protein kinase inhibitor
DESCRIPTION AND
COMPOSITION
PHARMACEUTICAL FORM(S)
Film-coated tablet
ACTIVE SUBSTANCE(S)
Each 200 mg tablet contains 216.7 mg of pazopanib hydrochloride, which
is
equivalent to 200
mg of pazopanib as free base.
Each 400 mg tablet contains 433.4 mg of pazopanib hydrochloride, which
is equivalent to 400
mg of pazopanib as free base.
EXCIPIENTS
Tablet core
Magnesium stearate;
microcrystalline cellulose;
povidone (K30);
sodium starch glycollate
Tablet coating
200 mg (Opadry Pink)
Hypromellose
Iron Oxide Red (E172)
Macrogol / PEG 400
Polysorbate 80
Titanium dioxide (E171)
400 mg (Opadry
White)
Hypromellose
Macrogol / PEG 400
Polysorbate 80
Titanium dioxide (E171)
Novartis
03 Jun 2021
Page 3
Malaysia Package Leaflet
Votrient
®
INDICATIONS
RENAL CELL CARCINOMA (RCC)
Votrient is indicated for the treatment of patients with advanced
and/or metastatic renal cell
carcinoma (RCC).
SOFT TISSUE SARCOMA (STS)
Votrient is indicated for the treatment of patients with advanced soft
tissue sarcoma (STS) who
have received prior chemotherapy.
The Phase III trial population excluded patients with gastrointestinal
stromal tumor (GIST) or
adipocytic STS.
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
GENERAL TARGET POPULATION
The recommended dose of Votrient is 800 mg orally once daily (see
Method of administration).
DOSE MODIFICATIONS
Dose modification, either an increase or decrease in dose, should be
in 200 mg increments in a
stepwise fashion based on individual tolerability in order to manage
adverse reactions. The daily
dose of Votrient should not exceed 800 mg.
SPECIAL POPULATIONS
RENAL IMPAIRMENT
Renal
impairment
is
not
expected
to
have
a
clinically
relevant
effect
on
Votrient
pharmacokinetics given the low renal excretion of pazopanib and
metabolites (see section
CLINICAL PHARMACOLOGY, Pharmacokinetics,
Elimination). Renal impairment is not
expected to influence pazopanib exposure, and dose adjustme